da Vinci Robotic System Still the Focus of Controversy

Although Intuitive Surgical, the maker of the da Vinci robotic surgical device, continues to tout the controversial system’s so-called benefits, mounting injury reports and litigation tell a different story.

David Rosa from Intuitive Surgical tells CNN that, “The benefit is minimally invasive surgery. The patient will feel less pain, need less time to recover, generally (lose) less blood depending on the operation. There’s just a raft, a whole host of benefits to the patient.” Not all of the experts agree and in the face of growing patient injuries, some hospitals are opting against using the technology, which is expensive—nearly $2 million.

Oncologist Dr. Ezekiel Emanuel, a former White House adviser, agreed with a 2012 op-ed piece published in The New York Times saying, “This is a pseudo-innovation … a technology that increases costs without improving patients’ health,” The Monterey Herald reported. According to Dr. Emanuel, a 2009 study revealed that although patients who underwent prostate surgery with the da Vinci experienced reduced hospital stays and less initial complications, such as blood loss, they experienced increased incontinence and erectile dysfunction later.

Many published trials critical of the da Vinci emphasize the device’s cost. For example, a study published this year in the Journal of the American Medical Association found that hysterectomies performed with the da Vinci cost about one-third more than traditional, minimally invasive hysterectomy procedures, but with similar surgical outcomes, according to The Monterey Herald.

da Vinci training protocols have also come under fire. Dr. Jim Hu, chief of minimally invasive surgery at the UCLA Medical School, urology department, performed over 1,500 da Vinci surgeries and has conducted many studies of the device. Dr. Hu explained that it takes about 250-700 procedures for a surgeon to master the da Vinci, according to The Monterey Herald. Not all hospitals mandate that surgeons conduct this many training procedures—so-called “proctored” surgeries and Intuitive only provides surgeons with two days of training. According to a report published in the Journal of Urology and discussed in the Wall Street Journal, a hospital would need to conduct about 520 da Vinci surgeries annually to ensure that robotic surgery costs remain consistent with non-da Vinci procedures. “Robotic surgery is clearly associated with higher costs, without any clear advantages,” said Dr. Jason Wright, a gynecologic surgeon and an author of a Columbia da Vinci study.

The U.S. Food and Drug Administration (FDA) recently criticized Intuitive Surgical saying that the device maker never reported the steps it took to protect patients from accidental electrical burns, according MedScape Medical News, citing a May 30 FDA inspection report. The report followed agency inspections conducted in April and May. Intuitive Surgical officials told MedScape Medical News that it “implemented corrective actions” for this and a number of other infractions cited.

Personal injury lawsuits brought over the da Vinci allege that the system caused severe internal injuries such as burns, tears, and other complications. Some procedures have led to chronic pain, disability, or death. Lawsuits also blame Intuitive’s aggressive marketing tactics, which appear to be meant to urge hospitals to purchase the expensive robotic device, and allege that design flaws inherent in the da Vinci, as well as poor physician training on the device, have led to serious injuries. Some 89 deaths have been associated with the da Vinci robotic surgical systems since 2009.

In robotic-assisted surgery, a surgeon sits at a console operating multiple robotic arms that manipulate tiny tools that are inserted into the patient’s body via small incisions. The system uses a small, lighted camera that displays the surgical area in 3-D video. The da Vinci is the only robotic surgery approved by the FDA for soft tissue surgeries.